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FEATURED EDITORIAL

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A Biotech Business Model That's Investor-Friendly

For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.

GUEST COLUMNISTS

The Real Reason We Haven't Fully Automated Cell Therapy Yet
Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.
The Firefighting Era Of Clinical Supply Chain Is Over. Here's What Replaces It
Clinical trial supply chains are evolving: digital twins, on-demand kits, and sustainable logistics replace reactive firefighting with precision, speed, and resilience.
The Hidden Engineering Behind Successful Upstream Bioprocessing
In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.
A Practical Look At Modern Downstream Processing For Biologics
Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.
Process Engineering's Key Role In Sterile Injectable Facility Design
Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
What To Know About — And How To Apply For — FDA's PreCheck Pilot
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
A Novel In Vitro Glycosylation Approach For Difficult PTMs
Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.

PHARMA OUTSOURCING WHITE PAPERS

Control Strategies And Method Development For Nitrosamines In APIs And Drug Products
Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.

Leveraging Efficiency From CLD To Clinical Manufacturing Of mAbs
Discover how our efficient strategies can propel your mAb from discovery to clinical manufacturing in as little as 18 months.
Streamline Your AAV Process With A Production Platform
AAVs are reshaping gene therapy, but scaling production introduces complexity. Learn how upstream process optimization can improve yield, consistency, and speed to meet growing demands.
Vial Fogging: Practical Considerations For Vial Selection
Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.
How Confident Are You In Your Autoinjector?
As demand for self-administered therapies accelerates, autoinjectors, formally known as automated needle-based injection systems (NIS-AUTO), are playing an increasingly central role in modern medicine.
Achieving Statistical Significance With Limited Patient Populations
Explore highlights from a timely panel debate on emerging approaches to clinical research and data collection for advanced, novel and personalized therapies, especially linked to rare diseases.